Efficacy of Selective COX-2 Inhibitors in Relieving Orthodontic Pain (EOSCOX2)
Efficacy of Selective COX-2 Inhibitors in Relieving Orthodontic Pain ;a Randomized Controlled Trial
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Lahore, Pakistan
- Sharif Medical City Lahore
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 13 to 30 years
- Fully erupted permanent dentition excluding third molars
- Mild crowding (0 -4mm)
Exclusion Criteria:
- Active periodontitis
- Deep cavities or large restorations
- Previous dental extraction in less than 4 weeks before bonding
- History of steroid use within last 6 weeks
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: Group A
Group A will be given Celecoxib medicine.
|
Group A will be given Celecoxib 50mg once a day.
|
|
Active Comparator: Group B
Group B will be given Etoricoxib medicine.
|
Group B will be given Etoricoxib 60mg once a day.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity
Time Frame: 1 year
|
Pain scores will be measured using a 10cm Visual Analogue Scale (VAS) , The Scale consists of a horizontal line anchored by two verbal descriptions where 0 represented '' No Pain '' and 10 represented ''Maximum Pain''.
The Score is determined by measuring the distance from left end of the scale to the mark made by the participant.
|
1 year
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Chair: Faiza Malik, BDS, FCPS, Essentia Health
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- SMDC/SMRC/289-23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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